Lessons from a trial of acupuncture and massage for low back pain: patient expectations and treatment effects.

STUDY DESIGN: A subanalysis of data derived from a randomized clinical trial was performed. OBJECTIVE: To evaluate the association of a patient's expectation for benefit from a specific treatment with improved functional outcome. SUMMARY OF BACKGROUND DATA: Psychosocial factors, ambiguous diagnoses, and lack of a clearly superior treatment have complicated the management of patients with chronic low back pain. The authors hypothesized that patient expectation for benefit from a specific treatment is associated with improved functional outcomes when that treatment is administered. METHODS: In a randomized trial, 135 patients with chronic low back pain who received acupuncture or massage were studied. Before randomization, study participants were asked to describe their expectations regarding the helpfulness of each treatment on a scale of 0 to 10. The primary outcome was level of function at 10 weeks as measured by the modified Roland Disability scale. RESULTS: After adjustment for baseline characteristics, improved function was observed for 86% of the participants with higher expectations for the treatment they received, as compared with 68% of those with lower expectations (P = 0.01). Furthermore, patients who expected greater benefit from massage than from acupuncture were more likely to experience better outcomes with massage than with acupuncture, and vice versa (P = 0.03). CONCLUSIONS: The results of this study suggest that patient expectations may influence clinical outcome independently of the treatment itself. In contrast, general optimism about treatment, divorced from a specific treatment, is not strongly associated with outcome. These results may have important implications for clinical trial design and recruitment, and may help to explain the apparent success of some conventional and alternative therapies in trials that do not control for patient expectations. The findings also may be important for therapy choices made in the clinical setting.

Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain.

BACKGROUND: Because the value of popular forms of alternative care for chronic back pain remains uncertain, we compared the effectiveness of acupuncture, therapeutic massage, and self-care education for persistent back pain. METHODS: We randomized 262 patients aged 20 to 70 years who had persistent back pain to receive Traditional Chinese Medical acupuncture (n = 94), therapeutic massage (n = 78), or self-care educational materials (n = 90). Up to 10 massage or acupuncture visits were permitted over 10 weeks. Symptoms (0-10 scale) and dysfunction (0-23 scale) were assessed by telephone interviewers masked to treatment group. Follow-up was available for 95% of patients after 4, 10, and 52 weeks, and none withdrew for adverse effects. RESULTS: Treatment groups were compared after adjustment for prerandomization covariates using an intent-to-treat analysis. At 10 weeks, massage was superior to self-care on the symptom scale (3.41 vs 4.71, respectively; P =.01) and the disability scale (5.88 vs 8.92, respectively; P<.001). Massage was also superior to acupuncture on the disability scale (5.89 vs 8.25, respectively; P =.01). After 1 year, massage was not better than self-care but was better than acupuncture (symptom scale: 3.08 vs 4.74, respectively; P =.002; dysfunction scale: 6.29 vs 8.21, respectively; P =.05). The massage group used the least medications (P<.05) and had the lowest costs of subsequent care. CONCLUSIONS: Therapeutic massage was effective for persistent low back pain, apparently providing long-lasting benefits. Traditional Chinese Medical acupuncture was relatively ineffective. Massage might be an effective alternative to conventional medical care for persistent back pain.

A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain.

BACKGROUND AND METHODS: There are few data on the relative effectiveness and costs of treatments for low back pain. We randomly assigned 321 adults with low back pain that persisted for seven days after a primary care visit to the McKenzie method of physical therapy, chiropractic manipulation, or a minimal intervention (provision of an educational booklet). Patients with sciatica were excluded. Physical therapy or chiropractic manipulation was provided for one month (the number of visits was determined by the practitioner but was limited to a maximum of nine); patients were followed for a total of two years. The bothersomeness of symptoms was measured on an 11-point scale, and the level of dysfunction was measured on the 24-point Roland Disability Scale. RESULTS: After adjustment for base-line differences, the chiropractic group had less severe symptoms than the booklet group at four weeks (P=0.02), and there was a trend toward less severe symptoms in the physical therapy group (P=0.06). However, these differences were small and not significant after transformations of the data to adjust for their non-normal distribution. Differences in the extent of dysfunction among the groups were small and approached significance only at one year, with greater dysfunction in the booklet group than in the other two groups (P=0.05). For all outcomes, there were no significant differences between the physical-therapy and chiropractic groups and no significant differences among the groups in the numbers of days of reduced activity or missed work or in recurrences of back pain. About 75 percent of the subjects in the therapy groups rated their care as very good or excellent, as compared with about 30 percent of the subjects in the booklet group (P<0.001). Over a two-year period, the mean costs of care were $437 for the physical-therapy group, $429 for the chiropractic group, and $153 for the booklet group. CONCLUSIONS: For patients with low back pain, the McKenzie method of physical therapy and chiropractic manipulation had similar effects and costs, and patients receiving these treatments had only marginally better outcomes than those receiving the minimal intervention of an educational booklet. Whether the limited benefits of these treatments are worth the additional costs is open to question.

Health consequences of pregnancy and childbirth as perceived by women and clinicians.

OBJECTIVE: To develop patient-centered outcome measures for clinical research by characterizing the effects of pregnancy and childbirth on functioning. METHODS: Five focus groups of mothers (n = 33) and three focus groups of clinicians (midwives [n = 8], obstetricians [n = 4], and family practitioners [n = 7]) were convened. Discussions were audiotaped and transcribed. Major narrative themes were identified by using two independent readers and were confirmed by participants and additional clinicians. RESULTS: Themes were grouped into four outcome domains: physical, psychologic, sexual, and social. Themes identified included lack of knowledge about postpartum health, emotional lability, sexual satisfaction, depression, parenting skills, body image, fatigue, and incontinence. Lack of knowledge about typical postpartum health was the dominant theme for mothers and clinicians. Mothers felt unprepared for the health consequences of pregnancy and delivery. Clinicians lamented that paucity of data made counseling and treating patients difficult. Decreased functioning months after delivery was reported. Differences between mother and clinician concerns surfaced, particularly in emphasis. Mothers wanted more information about their health; providers emphasized newborn care. Mothers reported inspiration to improve their economic circumstances; clinicians emphasized improving maternal health. Mothers wanted control during labor, whereas clinicians believed control was not always possible. CONCLUSION: Women often felt poorly prepared for the postpartum period in part because functional health consequences are not well understood. This study suggests maternal functional health may be decreased for months after delivery, even among uncomplicated patients. This study identified new maternal outcome measures, which are being incorporated into an outcomes questionnaire.

Drug therapy for back pain. Which drugs help which patients?

STUDY DESIGN: A brief review of current literature and issues on drug therapy for low back pain. OBJECTIVES: To identify current knowledge and future research needs related to drug therapy. SUMMARY OF BACKGROUND DATA: Drug therapy is one of many possible treatment choices for symptom relief in patients with low back pain. The variety of drugs used suggests that there is no uniquely successful form of drug therapy. One reason for uncertainty and slow progress in this area is the limited quality of many clinical trials for back pain, with inadequate description of patients and outcomes being common deficits. METHODS: A selective review of randomized trials and systematic literature syntheses on drug therapy is given. RESULTS: Despite limitations, there is good evidence to support the efficacy of nonsteroidal anti-inflammatory drugs for acute low back pain and fair evidence for the use of muscle relaxants. There is greater controversy about the use of corticosteroids, which have been administered orally, intramuscularly, and epidurally. There is conflicting evidence regarding epidural injection of corticosteroids, but one meta-analysis suggests they may provide a small symptomatic improvement for patients with radiculopathy. Trials of systemic steroids and antidepressant drugs for managing chronic pain are inconclusive. The only randomized trial of local anesthetic injection into trigger points suggested that this treatment was equivalent to that of saline injection, needling without injection, or vapo-coolant spray alone. CONCLUSION: It seems reasonable to recommend acetaminophen or nonsteroidal anti-inflammatory drugs for patients with acute back pain, with efforts to minimize costs and complications. Muscle relaxants and narcotic analgesics may be appropriate for some patients, but selection criteria are unclear, and these drugs should be prescribed for fixed periods. Drug treatment for chronic low back pain is less clear, and a current controversy centers on the use of chronic narcotic analgesics for such patients. Future research should include evaluating combinations of medications, combinations of medication and physical therapy, systemic corticosteroid therapy, trigger point injections, and narcotic use for patients with chronic pain. Spinal stenosis is common in the older population, and more drug trials are needed for this condition.

Clinical strategies for controlling costs and improving quality in the primary care of low back pain.

Back pain is a pervasive problem which ranks only behind cold symptoms as a reason for all physician visits. Among persons with back pain lasting at least two weeks, 85% will seek the care of a health professional. These patients obtain care from primary care physicians (Family Medicine, Internal Medicine, and Osteopathic physicians), but also see a variety of specialists, including physiatrists, rheumatologists, orthopedic surgeons, and neurosurgeons. Since any of these specialties may evaluate patients early in their course, it is important to adopt a systematic and rational early approach to back pain. This discussion emphasizes recent data suggesting that such an approach would include a parsimonious diagnostic evaluation, careful attention to patients' concerns, and careful choice of proven effective treatments. Specifically, we propose five strategies that may help to reduce costs of care while maintaining quality:1. Avoid premature or unnecessary diagnostic tests.2. Avoid patient deactivation.3. Avoid ineffective or unproven remedies.4. Prescribe effective therapy in a cost-conscious manner, and5. Emphasize lifestyle changes and patient self-efficacy.

A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain.

A number of treatments are widely prescribed for chronic back pain, but few have been rigorously evaluated. We examined the effectiveness of transcutaneous electrical nerve stimulation (TENS), a program of stretching exercises, or a combination of both for low back pain. Patients with chronic low back pain (median duration, 4.1 years) were randomly assigned to receive daily treatment with TENS (n = 36), sham TENS (n = 36), TENS plus a program of exercises (n = 37), or sham TENS plus exercises (n = 36). After one month no clinically or statistically significant treatment effect of TENS was found on any of 11 indicators of outcome measuring pain, function, and back flexion; there was no interactive effect of TENS with exercise. Overall improvement in pain indicators was 47 percent with TENS and 42 percent with sham TENS (P not significant). The 95 percent confidence intervals for group differences excluded a major clinical benefit of TENS for most outcomes. By contrast, after one month patients in the exercise groups had significant improvement in self-rated pain scores, reduction in the frequency of pain, and greater levels of activity as compared with patients in the groups that did not exercise. The mean reported improvement in pain scores was 52 percent in the exercise groups and 37 percent in the nonexercise groups (P = 0.02). Two months after the active intervention, however, most patients had discontinued the exercises, and the initial improvements were gone. We conclude that for patients with chronic low back pain, treatment with TENS is no more effective than treatment with a placebo, and TENS adds no apparent benefit to that of exercise alone.

Can trials of physical treatments be blinded? The example of transcutaneous electrical nerve stimulation for chronic pain.

Therapeutic trials often attempt to "blind" patient and investigator to the true nature of treatments received, reducing the influences of conscious or subconscious prejudices. In drug trials, this is accomplished with placebo tablets, but blinding in trials of physical treatments is more problematic. This issue arose in a clinical trial of transcutaneous electrical nerve stimulation (TENS) for patients with chronic low back pain. Several study design features were incorporated to promote blinding: use of sham TENS units visually identical with real units, exclusion of potential subjects with previous TENS experience, avoidance of a crossover design and use of identical visit frequency, instructions and modifications in electrode placement. Subjects were asked not to discuss treatments with the clinicians who performed outcome assessments. Both patients and clinicians were asked to guess actual treatment assignments at the trial's end. Every patient in the true TENS group believed the unit was functioning properly, but the degree of certainty varied. In the sham TENS group, 84% also believed they had functioning units, but their certainty was significantly less than in the active treatment group. Differences in patient perceptions did not affect compliance, as the two groups had similar dropout rates, appointment compliance, days of TENS use and daily duration of TENS use. Clinicians guessed treatments correctly 61% of the time (as opposed to 50% expected by chance), again suggesting partial success in blinding. These efforts at blinding may partly explain the negative trial results for TENS efficacy. We conclude that complete blinding is difficult to achieve because of sensory difference in treatment and unintended communication between patient and examiner.(ABSTRACT TRUNCATED AT 250 WORDS)

Prognostic variability among chronic pain patients: implications for study design, interpretation, and reporting.

Chronic pain patients share many characteristics, but there is important prognostic variability among them. By selecting for certain characteristics, different recruitment methods and entry criteria for clinical or research programs may influence the likelihood of success regardless of treatment efficacy. This was demonstrated when subjects (n = 55) were recruited through lay publicity for a clinical trial of therapy for chronic back pain. In comparison to routine pain clinic patients (n=61), subjects in the clinical trial were better educated, were more often employed, had more favorable personality profiles, and were less likely to have had surgery or narcotic use (all p less than 0.004). Pain relief was significantly better for clinical trial subjects, apparently due to baseline prognostic differences rather than uniquely efficacious therapy. We conclude that chronic pain patients vary in prognostically important ways; that recruitment methods and criteria strongly influence these characteristics; and that greater attention to these details is needed when interpreting and reporting clinical research.

A simple language-based acculturation scale for Mexican Americans: validation and application to health care research.

A simple scale for quantifying English use among Mexican Americans was constructed from four brief questions which proved to have excellent scaling characteristics by Guttman Scalogram Analysis in two independent data sets. Construct validity was established by significant associations of the scale with ethnicity, place of birth, generation within the United States, and type of neighborhood. Highly significant associations were found between scale scores and use of oral contraceptives, parity, "fatalism" regarding health, and attitudes toward folk healers. These associations remained significant (though weak) after controlling for education and family income. The language scale thus appears to be reliable and valid, to be capable of distinguishing meaningful subsets among the Mexican American population, and to be applicable to health care investigation.